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Trial record 34 of 452 for:    QUETIAPINE

Efficacy of Quetiapine in the Treatment of Patients With Schizophrenia and a Comorbid Substance Use Disorder

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ClinicalTrials.gov Identifier: NCT00156715
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : December 21, 2010
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
Augusta University
AstraZeneca
Information provided by (Responsible Party):
Alan Green, Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE September 6, 2005
First Posted Date  ICMJE September 12, 2005
Results First Submitted Date  ICMJE November 19, 2010
Results First Posted Date  ICMJE December 21, 2010
Last Update Posted Date March 14, 2018
Study Start Date  ICMJE March 2004
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2010)
Mean Number of Drinking Days Per Week [ Time Frame: 12 Weeks ]
Timeline Follow-back (TLFB) procedure was used at screening and baseline to establish current substance use, and it was also used weekly during the course of the study to assess continued alcohol and other substance use. TLFB cosisted of using a calendar and sasking participants to report alcohol and other drug use since last visit. At the screening visit, the TLFB was done for the four weeks prior to the visit.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
Substance use assessed by: self-report using the Timeline Followback, breathalyzer, urine drug tests, clinician ratings of alcohol/substance use, and blinded, consensus ratings of the Alcohol Use and Drug Use Scales using all available patient data.
Change History Complete list of historical versions of study NCT00156715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2010)
Clinical Symptoms [ Time Frame: 12 Weeks ]
The main outcome measure of clinical symptoms was the Positive and Negative Symptoms Scale. This is a 30 item scale for assessing patients diagnosed with schizophrenia. Each item is rated on a 1 (absent) to 7 (extreme) scale. The minimum total score is 30 and the maximum is 210.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
Clinical Symptoms: Positive and Negative Symptom Scale and Clinical Global Impression scale; Quality of life: Heinrich Quality of Life; Extrapyramidal system effects: Simpson-Angus Scale, Abnormal Involuntary Movements Scale, and Barnes Akathisia Scale.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Quetiapine in the Treatment of Patients With Schizophrenia and a Comorbid Substance Use Disorder
Official Title  ICMJE Efficacy of Quetiapine in Treating Patients With Active Substance Use Disorder and Schizophrenia
Brief Summary The purpose of this study is to examine the efficacy of quetiapine (Seroquel) in reducing substance use in persons diagnosed with schizophrenia. The primary hypothesis is that quetiapine treatment will be associated with a decrease in substance use.
Detailed Description

Comorbid alcohol/substance use disorder (SUD) in schizophrenia is a major concern, both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managing such patients. Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schizophrenia, the typical antipsychotic agents are of limited value in controlling alcohol/substance use in these patients. Extrapyramidal, dysphoric side effects of conventional neuroleptics may actually promote the use of substances in an attempt to counteract these effects.

Novel antipsychotics have radically altered treatment expectations and outcomes for patients with severe forms of schizophrenia. With the greater availability of novel agents in clinical practice, it has been noted that these benefits have also extended to specific subgroups of patients including patients with comorbid SUD. Several retrospective studies have demonstrated a decrease in comorbid substance use in patients with schizophrenia treated with clozapine. There is little data available, however, on the efficacy of quetiapine in patients with schizophrenia and comorbid SUD. Its receptor profile, including a weak Dopamine2 (D2) receptor blocking ability and substantial effects at noradrenergic receptors, makes it a logical antipsychotic to use in the comorbid population.

The study is an open-label investigation of the efficacy of quetiapine in a group of 30 patients with schizophrenia and comorbid substance use disorder. Patients diagnosed with schizophrenia or schizoaffective disorder and a comorbid substance use disorder are switched to quetiapine for 12 weeks. We hypothesize that quetiapine treatment will be associated with a decrease in substance use. Moreover, we further hypothesize that measures of symptoms, cognition and quality of life will also improve over baseline assessments in patients treated with quetiapine. Data suggesting a beneficial effect of quetiapine will have to be confirmed in a prospective double-blind study. This pilot investigation will provide preliminary data and effect sizes that will be used in the design of this subsequent investigation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
  • Psychotic Disorder
  • Substance Abuse
  • Alcohol Abuse
Intervention  ICMJE Drug: Quetiapine
After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
Other Name: Seroquel
Study Arms  ICMJE Experimental: Quetiapine
After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
Intervention: Drug: Quetiapine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2010)
23
Original Enrollment  ICMJE
 (submitted: September 7, 2005)
30
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-65
  • Schizophrenia or schizoaffective disorder
  • Meets Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) criteria for a substance use disorder (alcohol use disorder [AUD]; abuse or dependence)
  • Active substance use on at least 8 days during the 4 weeks prior to randomization.
  • Current treatment with antipsychotic medication.
  • Able to provide informed consent, or in the case of patients with legal court appointed guardians willing to give assent, with the consent of the guardian.
  • Not actively suicidal.

Exclusion Criteria:

  • Current treatment with, decanoate antipsychotic, clozapine, or doses of quetiapine not approved by the team of investigators. Individuals treated with depot antipsychotic must wait until the end of their injection cycle before starting on study medication.
  • Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
  • Currently residing in a residential program designed to treat substance use disorders.
  • Treatment at baseline with a psychotropic agent proposed to curtail substance use.
  • Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study.
  • Unable to take part in the assessments in a meaningful way
  • Hypersensitivity/intolerance to quetiapine
  • Serious, unstable medical condition
  • Participation in clinical trial of an investigational drug within 30 days of baseline visit, or concurrent participation in a treatment study of a psychosocial intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00156715
Other Study ID Numbers  ICMJE 16563
IRUSQUET0063 ( Other Grant/Funding Number: AstraZeneca )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alan Green, Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE
  • Augusta University
  • AstraZeneca
Investigators  ICMJE
Principal Investigator: Alan I Green, MD Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP